This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
594
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Sham administered on Day 1, Week 16, and Week 32.
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)
IOP in the Study Eye at Week 2 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 2 (Hour 0)
IOP in the Study Eye at Week 2 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 2 (Hour 2)
IOP in the Study Eye at Week 6 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
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Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Arizona Glaucoma Specialists
Phoenix, Arizona, United States
Lugene Eye Institute
Glendale, California, United States
Lakeside Vision Center
Irvine, California, United States
Hamilton Glaucoma Center, Shiley Eye Center UCSD
La Jolla, California, United States
Atlantis Eye Care
Long Beach, California, United States
Glaucoma Institute of Beverly Hills
Los Angeles, California, United States
Montebello Medical Eye Center Inc.
Montebello, California, United States
Stanford University
Palo Alto, California, United States
Foothill Eye Institute
Pasadena, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
...and 96 more locations
Time frame: Week 6 (Hour 0)
IOP in the Study Eye at Week 6 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 6 (Hour 2)
IOP in the Study Eye at Week 12 (Hour 0)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 12 (Hour 0)
IOP in the Study Eye at Week 12 (Hour 2)
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Time frame: Week 12 (Hour 2)
Change From Baseline in IOP in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)